ISO/TC 215 NZ Hui May 2024

Communities Standards
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ISO/TC 215 NZ

This is our national mirror committee of the ISO/TC 215 Health informatics technical committee. Members are appointed by the Standards Approval Board of Standards New Zealand. Our purpose is to have input to new and updated ISO standards through working groups and the ballot process. Having operated behind the scenes for a couple of years, we’re now sharing our work with the wider ehealthforum community.

AGENDA

  • International Patient Summary (IPS) version 2 project update @alastairk and @keithduddy
  • Update on recommended purchases of ISO standards. Agreed with HISO that ISO/TC 215 NZ will provide recommendations on standards choices for national adoption to meet needs of major programmes such as Hira
  • Around the other working groups (if you have an update)
  • ‘Open notes’
  • Upcoming ballots (see below)
  • Any other business

Your ideas welcome

Around the working groups

  • ISO/TC 215/SC 1 Genomics Informatics
  • ISO/TC 215/WG 1 Architecture, Frameworks and Models @alastairk @keithduddy
  • ISO/TC 215/WG 2 Systems and Device Interoperability @amyc
  • ISO/TC 215/WG 3 Semantic content
  • ISO/TC 215/WG 4 Security, Safety and Privacy
  • ISO/TC 215/WG 6 Pharmacy and medicines business
  • ISO/TC 215/WG 10 Traditional Medicine
  • ISO/TC 215/WG 11 Personalized digital health @angela.pidd
  • ISO/TC 215/TF 7 Task Force on Telehealth and Virtual Care (TVC) Standards @i.hunter @atalagk

Upcoming ballots

We’ll walk through these, make a decision on the no-brainers and allocate the rest for further investigation

Item Type Reference Due date Title Outcome/Action
1 CIB N4489 - call for new JWG 7 convenor 31 May 2024 N4489 - call for new JWG 7 convenor
2 SR ISO/IEEE 11073-10207:2019 03 Jun 2024 Health informatics — Personal health device communication — Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
3 SR ISO/IEEE 11073-10419:2019 (Ed 2) 03 Jun 2024 Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
4 SR ISO/TS 22272:2021 03 Jun 2024 Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures
5 SR ISO/TR 80001-2-6:2014 03 Jun 2024 Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
6 SR ISO/TR 80001-2-7:2015 03 Jun 2024 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
7 CIB N4512 - Call for experts ISO 27269 IPS Maintenance Agency 07 Jun 2024 N4512 - Call for experts ISO 27269 IPS Maintenance Agency
8 CIB N4526 - Call for experts Revision TS 22789 18 Jun 2024 N4526 - Call for experts Revision TS 22789 Conceptual framework for patient findings and problems in terminologies
9 CIB N4527 - Call for experts Revision 16791 18 Jun 2024 N4527 - Call for experts Revision 16791 Requirements for international machine-readable coding of medicinal product package identifiers
10 CIB N4528 - Call for experts and PL for rev 21091 18 Jun 2024 N4528 - Call for experts and PL for pontetial revision of ISO 21091 Directory services for healthcare providers, subjects of care and other entities
11 FDIS ISO/IEEE FDIS 11073-10206 20 Jun 2024 Health informatics — Device interoperability — Part 10206: Personal health device communication — Abstract content information model
12 DTS ISO/DTS 5384 26 Jun 2024 Health informatics — Categorial structure and data elements for the identification and exchange of immunization data
13 DTS ISO/DTS 9320 15 Jul 2024 Health informatics — Standardized data set for transfer of hemodialysis patients
14 CD ISO/CD 17090-4 15 Jul 2024 Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents
15 NP ISO/PWI TS 20731 22 Jul 2024 Health informatics --Information model of Prakriti in Ayurveda Informatics
16 CIB N4509 - JWG 3 NWIP 22989-2 27 Jul 2024 N4509 - JWG 3 NWIP 22989-2 AI - Concepts and terminology - Part 2 Healthcare
17 FDIS ISO/IEEE FDIS 11073-10421 (Ed 2) 02 Aug 2024 Health informatics — Device interoperability — Part 10421: Personal Health Device Communication — Device Specialization- Peak expiratory flow monitor (peak flow)
18 FDIS ISO/IEEE FDIS 11073-10425 (Ed 3) 29 Aug 2024 Health informatics — Device interoperability — Part 10425: Personal Health Device Communication — Device Specialization- Continuous Glucose Monitor (CGM)
19 FDIS ISO/IEEE FDIS 11073-10471 (Ed 2) 29 Aug 2024 Health informatics — Device interoperability — Part 10471: Personal Health Device Communication — Device Specialization- Independent Living Activity Hub
20 FDIS ISO/IEEE FDIS 11073-10472 (Ed 2) 29 Aug 2024 Health informatics — Device interoperability — Part 10472: Personal Health Device Communication — Device Specialization — Medication Monitor
21 FDIS ISO/IEEE FDIS 11073-10700 29 Aug 2024 Health informatics — Device interoperability — Part 10700: Point‐of‐Care Medical Device Communication –Standard for Base Requirements for Participants in a Service‐Oriented Device Connectivity (SDC) System
22 FDIS ISO/IEEE FDIS 11073-10701 29 Aug 2024 Health informatics — Device interoperability — Part 10701: Point-of-Care Medical Device Communication – Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System
23 SR ISO/IEEE 11073-10418:2014 (vers 2) 02 Sep 2024 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
24 SR ISO 13120:2019 (Ed 2) 02 Sep 2024 Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML)
25 SR ISO 13606-1:2019 (Ed 2) 02 Sep 2024 Health informatics — Electronic health record communication — Part 1: Reference model
26 SR ISO 13606-2:2019 (Ed 2) 02 Sep 2024 Health informatics — Electronic health record communication — Part 2: Archetype interchange specification
27 SR ISO 13606-3:2019 (Ed 2) 02 Sep 2024 Health informatics — Electronic health record communication — Part 3: Reference archetypes and term lists
28 SR ISO 13606-4:2019 02 Sep 2024 Health informatics — Electronic health record communication — Part 4: Security
29 SR ISO 13606-5:2019 (Ed 2) 02 Sep 2024 Health informatics — Electronic health record communication — Part 5: Interface specification
30 SR ISO 21549-2:2014 (Ed 2, vers 2) 02 Sep 2024 Health informatics — Patient healthcard data — Part 2: Common objects
31 SR ISO 21549-3:2014 (Ed 2, vers 2) 02 Sep 2024 Health informatics — Patient healthcard data — Part 3: Limited clinical data
32 SR ISO 21549-4:2014 (Ed 2, vers 2) 02 Sep 2024 Health informatics — Patient healthcard data — Part 4: Extended clinical data
33 SR ISO/TS 22077-5:2021 02 Sep 2024 Health informatics — Medical waveform format — Part 5: Neurophysiological signals
34 SR ISO/TS 22691:2021 02 Sep 2024 Health informatics — Token-based health information sharing
35 SR ISO 22857:2013 (Ed 2, vers 2) 02 Sep 2024 Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health data
36 SR ISO/TS 23541-1:2021 02 Sep 2024 Health informatics — Categorial structure for representation of 3D human body position system — Part 1: Bones

Key to the various ballot types:

  • Draft Technical Report (DTR)
  • Committee Internal Ballot (CIB)
  • Committee Draft (CD)
  • Final Draft International Standard (FDIS)
  • Systematic Review (SR)
  • New Proposal (NP)

Any other business

2

Kia ora, sorry I am very ill today so will not be able to join.

3

Happy to take some summary notes including actions & outcomes

2 Likes
4

Below are the medical device proposals at “Final Draft International Standard (FDIS)” stage from today’s agenda. The pending decisions for all of them are:
“Do you approve the technical content of the final draft?”
The recommendation choices are
• Approval
• Approval with corrections*
• Disapproval *
• Abstention
(* Comment required)
We agreed today that, absent other information, we support these proposed standards (approve). If, upon reading the details, you have other questions or input, I suggest you advise Alastair not later than the day before the due date.

# Name and document link Summary Due date
17 Health informatics — Device interoperability — Part 10421: Personal Health Device Communication — Device Specialization- Peak expiratory flow monitor (peak flow) https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1368988&versionId=1 This second edition cancels and replaces the first edition (ISO/IEEE 11073-10421:2012), which has been technically revised. (p.iii) The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic. Purpose This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is key to growing the potential market for these devices and enabling people to be better informed participants in the management of their health. 2/8/24
18 Health informatics — Device interoperability — Part 10425: Personal Health Device Communication — Device Specialization- Continuous Glucose Monitor (CGM) https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1372533&versionId=1 This third edition cancels and replaces the second edition (ISO/IEEE 11073-10425:2019), which has been technically revised. (p. iii) Within the context of the ISO/IEEE 11073 fmily of standards for device communication, a normative definition of the communication between continuous glucose monitor (CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person. 29/8/24
19 Health informatics — Device interoperability — Part 10471: Personal Health Device Communication — Device Specialization- Independent Living Activity Hub https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1372531&versionId=1 This second edition cancels and replaces the first edition (ISO/IEEE 11073-10421:2012), which has been technically revised. (p.iii) Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth independent living activity hub devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth independent living activity hubs is defined in this standard. 29/8/24
20 Health informatics — Device interoperability — Part 10700: Point‐of‐Care Medical Device Communication –Standard for Base Requirements for Participants in a Service‐Oriented Device Connectivity (SDC) System https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1372529&versionId=1 Medical devices that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a health IT system to jointly execute system functions. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of system functions resulting from the combination of system function contributions from two or more medical devices. SDC participant key purposes (PKPs) are sets of requirements that allow for manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform risk management, verification, validation, and usability engineering for the safe use of system functions. This standard defines requirements for SDC metric participants in an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system functions based on the exchange of metric information. 29/8/24
21 Health informatics — Device interoperability — Part 10700: Point‐of‐Care Medical Device Communication –Standard for Base Requirements for Participants in a Service‐Oriented Device Connectivity (SDC) System https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1372529&versionId=1 Medical devices that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a health IT system to jointly execute system functions. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of system functions resulting from the combination of system function contributions from two or more medical devices. SDC participant key purposes (PKPs) are sets of requirements that allow for manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform risk management, verification, validation, and usability engineering for the safe use of system functions. This standard defines requirements for SDC metric participants in an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system functions based on the exchange of metric information 29/8/24
22 Health informatics — Device interoperability — Part 10701: Point-of-Care Medical Device Communication – Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System https://isotc.iso.org/livelink/eb3/download/file.pdf?attachmentId=1372530&versionId=1 This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements. 29/8/24
My notes from the meeting today, please reply with any corrections/additions:

Attending: Alastair Kenworthy, Susanne Ames, Keith Duddy, Angela Pidd, Inga Hunter, Micah Davison, Nathan Billing, Evan Li, Samuel Wong

Apologies: Amy Chen, Derek Buchanan, Koray Atalag

Introductions: Welcome Evan

Agenda

  • International Patient Summary (IPS) version 2 project update @alastairk and @keithduddy:
  • Update on recommended purchases of ISO standards. Agreed with HISO that ISO/TC 215 NZ will provide recommendations on standards choices for national adoption to meet needs of major programmes such as Hira: Samuel has ID’d Health NZ standards 60 most important. Paying a sub to access. ISO has commercial business model.

Action : Alastair will try to get access for those of us outside Health NZ. If you want to get access, create an account on Standards NZ website

Around the working groups:

ISO/TC 215/WG 11 Personalized digital health Action: Angela will share information with Micah who is interested in joining.

  • ‘Open notes’: This committee is now available to everyone in ehealthforum.nz going forward.
  • Upcoming ballots (see below)
Agenda item Due Name and reference Outcome and notes
1 31 May 2024 N4489 - call for new JWG 7 convenor Safe effective secure health software. Pass.
2 03 Jun 2024 ISO/IEEE 11073-10207:2019 Health informatics — Personal health device communication — Part 10207: Domain information and service model for service-oriented point-of-care medical device communication 1 Support
3 03 Jun 2024 ISO/IEEE 11073-10419:2019 (Ed 2) Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump Support
4 03 Jun 2024 ISO/TS 22272:2021 Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures Support
5 03 Jun 2024 ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements Support
6 03 Jun 2024 ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 Support
7 07 Jun 2024 N4512 - Call for experts ISO 27269 IPS Maintenance Agency N4512 - Call for experts ISO 27269 IPS Maintenance Agency 1 National agency that maintains codes. The IPS will keep changing. They want a chair and a secretary, clinical background preferred. It’s useful to know where things are going, especially political issues. Action: Inga interested if not too much work, gets NZ a seat at the table.
8 18 Jun 2024 N4526 - Call for experts Revision TS 22789 N4526 - Call for experts Revision TS 22789 Conceptual framework for patient findings and problems in terminologies We did not support this previously so we will say no. Not well enough linked to SNOMED.
9 18 Jun 2024 N4527 - Call for experts Revision 16791 N4527 - Call for experts Revision 16791 Requirements for international machine-readable coding of medicinal product package identifiers We currently don’t have a meds expert. Feel free to suggest others to Alastair.
10 18 Jun 2024 N4528 - Call for experts and PL for rev 21091 N4528 - Call for experts and PL for pontetial revision of ISO 21091 Directory services for healthcare providers, subjects of care and other entities We have debated this before. This standard might interfere with what NZ is doing. Action: Samuel to respond to Alastair because it sits in his scope
11 20 Jun 2024 ISO/IEEE FDIS 11073-10206 Health informatics — Device interoperability — Part 10206: Personal health device communication — Abstract content information model Support (sits alongside items 17-22)
12 26 Jun 2024 ISO/DTS 5384 Health informatics — Categorial structure and data elements for the identification and exchange of immunization data Support, will make it easier for international interoperability about immunisations
13 15 Jul 2024 ISO/DTS 9320 Health informatics — Standardized data set for transfer of hemodialysis patients Support
14 15 Jul 2024 ISO/CD 17090-4 Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents Action: Ask Derek to review as security expert. Also Samuel and Keith. Samuel is working on digital id. What happens if we take a different stance in NZ (myHealthaccount)? Our decisions don’t bind NZ. Might be use cases eg patient summary going offshore, digital trust framework. Be aware of compatibility. Also, provider signature. GS1 – successful for providers internationally.
15 22 Jul 2024 ISO/PWI TS 20731 Health informatics --Information model of Prakriti in Ayurveda Informatics We have usually passed on traditional medicine. Abstain.
16 27 Jul 2024 N4509 - JWG 3 NWIP 22989-2 N4509 - JWG 3 NWIP 22989-2 AI - Concepts and terminology - Part 2 Healthcare Robin Whitaker, Chris Pheon?
17 02 Aug 2024 ISO/IEEE FDIS 11073-10421 (Ed 2) Health informatics — Device interoperability — Part 10421: Personal Health Device Communication — Device Specialization- Peak expiratory flow monitor (peak flow) Support
18 29 Aug 2024 ISO/IEEE FDIS 11073-10425 (Ed 3) Health informatics — Device interoperability — Part 10425: Personal Health Device Communication — Device Specialization- Continuous Glucose Monitor (CGM) Support
19 29 Aug 2024 ISO/IEEE FDIS 11073-10471 (Ed 2) Health informatics — Device interoperability — Part 10471: Personal Health Device Communication — Device Specialization- Independent Living Activity Hub Support
20 29 Aug 2024 ISO/IEEE FDIS 11073-10472 (Ed 2) Health informatics — Device interoperability — Part 10472: Personal Health Device Communication — Device Specialization — Medication Monitor Support
21 29 Aug 2024 ISO/IEEE FDIS 11073-10700 Health informatics — Device interoperability — Part 10700: Point‐of‐Care Medical Device Communication –Standard for Base Requirements for Participants in a Service‐Oriented Device Connectivity (SDC) System Support
22 29 Aug 2024 ISO/IEEE FDIS 11073-10701 Health informatics — Device interoperability — Part 10701: Point-of-Care Medical Device Communication – Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System Support
23 02 Sep 2024 ISO/IEEE 11073-10418:2014 (vers 2) Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor Support
24 02 Sep 2024 ISO 13120:2019 (Ed 2) Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML) 1 Action: Alastair to reach out to John Carter
25 02 Sep 2024 ISO 13606-1:2019 (Ed 2) Health informatics — Electronic health record communication — Part 1: Reference model Support: NZ doesn’t use open EHR but it is useful to keep around.
26 02 Sep 2024 ISO 13606-2:2019 (Ed 2) Health informatics — Electronic health record communication — Part 2: Archetype interchange specification Support: NZ doesn’t use open EHR but it is useful to keep around.
27 02 Sep 2024 ISO 13606-3:2019 (Ed 2) Health informatics — Electronic health record communication — Part 3: Reference archetypes and term lists Support: NZ doesn’t use open EHR but it is useful to keep around.
28 02 Sep 2024 ISO 13606-4:2019 Health informatics — Electronic health record communication — Part 4: Security Support: NZ doesn’t use open EHR but it is useful to keep around.
29 02 Sep 2024 ISO 13606-5:2019 (Ed 2) Health informatics — Electronic health record communication — Part 5: Interface specification Support: NZ doesn’t use open EHR but it is useful to keep around.
30 02 Sep 2024 ISO 21549-2:2014 (Ed 2, vers 2) Health informatics — Patient healthcard data — Part 2: Common objects
31 02 Sep 2024 ISO 21549-3:2014 (Ed 2, vers 2) Health informatics — Patient healthcard data — Part 3: Limited clinical data
32 02 Sep 2024 ISO 21549-4:2014 (Ed 2, vers 2) Health informatics — Patient healthcard data — Part 4: Extended clinical data
33 02 Sep 2024 ISO/TS 22077-5:2021 Health informatics — Medical waveform format — Part 5: Neurophysiological signals
34 02 Sep 2024 ISO/TS 22691:2021 Health informatics — Token-based health information sharing
35 02 Sep 2024 ISO 22857:2013 (Ed 2, vers 2) Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health data 1
36 02 Sep 2024 ISO/TS 23541-1:2021 Health informatics — Categorial structure for representation of 3D human body position system — Part 1: Bones

VI. Any other business:
Action: Susanne will draft up our default approaches to these items and share for discussion before the August meeting.

5

@i.hunter looking at the ballot results, I see there are seven countries nominating an expert to make up the new International Patient Summary (IPS) Maintenance Agency - let’s hope yours is well received

6

And congratulations @i.hunter on making it to the new IPS Maintenance Agency - fantastic to have your expertise there as well as a Kiwi voice